CEL-SCI Announces Acceptance of Abstracts to ASCO 2022

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) announced acceptance of two abstracts related to its Phase 3 clinical trial for head and neck cancer at the American Society of Clinical Oncology (ASCO) meeting from June 3-7, 2022, in Chicago, IL. Over 890,000 new cases of head and neck cancer are diagnosed annually worldwide, with 68,000 in the U.S. CEL-SCI's Multikine, an investigational immunotherapy, targets early intervention before conventional treatments, aiming to enhance survival rates. The pivotal study enrolled 928 patients, marking it as the largest of its kind globally.

Positive

• Two abstracts accepted at ASCO 2022 indicate recognition in the medical community.
• Multikine is designed for early intervention, a unique approach compared to other therapies.
• The study is the largest Phase 3 trial for head and neck cancer, suggesting significant potential.

Negative

• Multikine has not yet received FDA approval, indicating regulatory risks.
• The reliance on past clinical results raises concerns about reproducibility in future studies.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that two abstracts related to CEL-SCI’s pivotal Phase 3 head and neck cancer clinical trial were accepted at the American Society of Clinical Oncology (ASCO) meeting being held June 3-7, 2022 in Chicago, IL. After a two-year hiatus, ASCO comes alive in June 2022 under the theme, “Advancing Equitable Cancer Care Through Innovation.” ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.

About Multikine

Multikine* (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain a mixture of natural human proinflammatory cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf, non-autologous biological investigational product, Multikine is manufactured using a proprietary process following Current Good Manufacturing Practice (cGMP) at CEL-SCI’s manufacturing facility near Baltimore, Maryland.

About Head and Neck Cancer

Approximately 890,000 new cases of head and neck cancer are diagnosed each year globally, of which approximately 68,000 are in the U.S. and 150,000 in Europe.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in its pivotal Phase 3 study of Multikine in newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck the investigational product Multikine was administered BEFORE patients received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care (SOC) for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed or to patients whose tumors have metastasized or are inoperable. Multikine (Leukocyte Interleukin, Injection), received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.

Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 events (deaths) had occurred among the two main comparator groups. This study milestone occurred in late April 2020 and database lock occurred in December 2020.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

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COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460



MEDIA CONTACT:

John F. Kouten

JFK Communications, Inc.

609-241-7352

jfkouten@jfkhealth.com

Source: CEL-SCI Corporation

FAQ

What does CEL-SCI Corporation's recent press release announce?

The press release announces the acceptance of two abstracts at the ASCO 2022 meeting regarding its Phase 3 head and neck cancer trial.

When is the ASCO 2022 meeting where CEL-SCI will present?

The ASCO 2022 meeting will be held from June 3-7, 2022, in Chicago, IL.

What is Multikine and what is its purpose?

Multikine is an investigational cancer immunotherapy designed to boost the immune system in newly diagnosed head and neck cancer patients.

How many patients were enrolled in CEL-SCI's Phase 3 study?

The Phase 3 study enrolled 928 patients, making it the largest study for advanced primary head and neck cancer.

What are the global statistics for head and neck cancer?

Approximately 890,000 new cases of head and neck cancer are diagnosed globally each year, with about 68,000 cases in the U.S.

What potential risks are associated with CEL-SCI's Multikine treatment?

Multikine has not yet received FDA approval, posing regulatory risks, and there are concerns about the reproducibility of clinical results.